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Medical Policy: 06.01.19
Original Effective Date: February 2003
Reviewed: September 2011
Revised: September 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Given the poor prognosis of lung cancer, there has been longstanding research interest in developing screening techniques for those at high risk. Previous studies of serial sputum samples of chest x-rays failed to demonstrate that screening improved health outcomes. More recently there has been interest in low-dose computed tomography (CT) scanning as a screening technique, using either spiral (also referred to as helical) or electron beam (also referred to as ultrafast) CT scanning. Compared to conventional CT scans, these scans allow for the continuous acquisition of images, thus shortening the scan time and radiation exposure. A complete CT scan can be obtained within 10-20 seconds, or during 1 breath hold, in the majority of patients. The radiation exposure for this examination is greater than for that of a chest x-ray but less than for a conventional CT scan.
Findings from a large randomized controlled trial in the United States evaluating the impact of screening with low-dose CT on lung cancer morbidity and mortality, the National Lung Screening trial (NLST), were published in 2011. In addition, several smaller European randomized controlled trials are ongoing. The NLST, sponsored by the National Institutes of Health (NIH) was launched in 2002. By April 2004, 53,454 current or former smokers from 33 sites in the U.S. had been randomly assigned to screening in 3 consecutive years with either a chest x-ray or low-dose spiral CT. Study eligibility included being between the ages of 55 and 74 years of age, having a history of cigarette smoking of at least 30 pack-years and, for former smokers, quitting within the past 15 years. Individuals with a previous diagnosis of lung cancer or who had signs and/or symptoms suggestive of lung cancer were excluded. There was no study-wide diagnostic follow up algorithm; individuals who had a positive test were managed according to protocols at the local center. A total of 95% of participants in the low-dose CT group and 93% in the radiography adhered to the screening protocol. In October 2010, the independent safety and monitoring board determined sufficient data were available to conclude that there was a statistically significant reduction in the primary outcome, lung cancer mortality. Consequently, the trial was terminated, and study results that occurred through December 31, 2009 were analyzed and reported.
During a median 6.5 year follow-up, a total of 356 of 26,722 (1.33%) participants in the low-dose CT group and 443 of 26,732 (1.66%) participants in the radiography group died of lung cancer, representing a relative risk reduction of 20% (95% confidence interval [CI]: 6.8% to 26.7%, p=0.004). Using intention-to-treat analysis, the absolute risk reduction was 0.33% and the number needed to screen (NNS) for three years with a low-dose CT to prevent one death from lung cancer was 303. The authors reported an NNS of 320 based on per-protocol data form participants who underwent at least one screen.
Overall mortality, a secondary outcome, was also significantly reduced in the low-dose CT screening group. There were a total of 1877 deaths (7.0%) in the low-dose CT group and 2000 (7.5%) deaths in the radiography group-relative risk reduction 6.7% (95% CI: 1.2% to 13.6%, p=0.02); absolute risk reduction of 0.46% and the NNS of 219 (95% CI: 111 to 5556).
The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all 3 screenings. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The remaining 649 tests (3.6% of total positive tests) in the low-dose CT scan group and 279 (5.5% of total positive tests) in the radiography group were confirmed lung cancers. During the screening phase, a total of 39.1% of participants in the low-dose CT group and 16.0% of those in the radiography group had at least one positive screening test.
During follow-up, 1060 lung cancers were identified in the low-dose CT group and 941 lung cancers were identified in the radiography group. The difference in the cancer rates between groups was statistically significant, with a rate ratio of 1.13 (95% CI: 6.8 to 26.7, p=0.004). In addition to the screen-detected cancers, 44 cancers in the low-dose CT group and 137 in the radiography group were diagnosed after a negative screen. Three hundred sixty-seven cancers in the low-dose CT group and 525 cancers in the radiography group were diagnosed among participants who had either missed screening or who had completed their 3 screenings.
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Prior Approval:
Not applicable
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Policy:
Low-dose computed tomography (CT) scanning may be considered medically necessary as a screening technique for lung cancer in individuals who meet ALL of the following criteria*:
- Between 55 and 74 years of age
- History of cigarette smoking of at least 30 pack-years
- If former smoker, quit within the previous 15 years
*Patient selection criteria are based in the National Lung Screening trial.
Low-dose computed tomography (CT) scanning as a screening technique for lung cancer in individuals not meeting ALL of the above criteria is considered investigational.
In summary, the National Lung Screening trial was a large, well-conducted trial. It found a statistically significantly lower rate of lung cancer mortality with 3 annual CT screens compared to chest radiographs. The study also found a statistically significant but modestly lower overall mortality in the low-dose CT group. There was a high rate of follow-up imaging tests but relatively low rates of invasive tests. Findings of the trial cannot be generalized to other populations, e.g., younger individuals or lighter smokers. The NLST evaluated the utility of a series of 3 annual CT screens; the efficacy of other screening regimens is not known.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 71250 Computed tomography, thorax; without contrast material
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Selected References:
- Mahadevia PJ, Fleisher LA, Frick KD, Eng J, Goodman SN, Powe NR. Lung cancer screening with helical computed tomography in older adult smokers. A decision and cost effective analysis. JAMA 2002;289(3)313-322.
- Gohagan J, Marcus P, Fagerstrom R, Pinsky P, Kramer B, Prorok P; Writing Committee, Lung Screening Study Research Group. Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute. Chest. 2004 Jul;126(1):114-21.
- Institute for Clinical Systems Improvement (ICSI). Computed tomography screening for lung cancer. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); February 2001. ICSI Technology Assessment Report #52.
- ECRI. Computed tomography for lung cancer screening. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2005 Jan. (Health Technology Forecast Report).
- ECRI. Helical computed tomography (CT) for lung cancer screening. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2004 July. TARGET [database online].
- Swensen SJ, Jett JR, Hartmen TE et al. CT screening for lung cancer: five-year prospective experience. Radiology. 2005 Apr;235(1):259-65.
- Henschke CI, Yankelevitz DF, Miettinen OS. Computed Tomographic Screening for Lung Cancer: The Relationship of Disease Stage to Tumor Size. Arch Intern Med 2006; 166:321-25.
- Lindell RM, Hartman TE, Swensen SJ et al. Five-year Lung Cancer Screening Experience: CT Appearance, Growth Rate, Location, and Histologic Features of 61 Lung Cancers. Radiology. 2007 Feb;242(2):555-62.
- The Early Lung Cancer Action Program Investigators. Survival of Patients with Stage I Lung Cancer Detected on CT Screening. N Engl J Med. 2006;355:1763-1771.
- Bach PB, Jett JR, Pastorino U et al. Computed Tomography Screening and Lung Cancer Outcomes. JAMA. 2007;297:953-961.
- Black C, de Verteuil R, Walker S, Ayres J, Boland A, Bagust A, Waugh N. Population screening for lung cancer using computed tomography, is there evidence of clinical effectiveness? A systematic review of the literature. Thorax, 2007 Feb;62(2):131-8.
- American Society of Clinical Oncology (ASCO) 45th Annual Meeting: Abstract CRA 1502. Presented May 30, 2009.
- Bach PB, Silvestri GA, Hanger M et al. Screening for Lung Cancer. ACCP Evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep; 132 (3 Suppl) 69S-77S.
- Hocking WG, Oken MM, Winslow SD et al. Lung cancer screening in the randomized prostate, lung, colorectal and ovarian (PLCO) cancer screening trial. J Natl Cancer Inst 2010; 102(10):722-31.
- van Klaveren RJ Oudkerk M, Prokop M et al. Management of lung nodules detected by volume CT screening. N Engl J Med 2009; 361(23):2221-9.
- Croswell JM, Baker SG, Marcus PM et al. Cumulative incidence of false-positive test results in lung cancer screening. Ann Intern Med 2010; 152(8):505-12.
- National Lung Cancer Screening Trial Research Team; Aberle DR, Adams AM, Berg CD et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011; 365(5):395-409.
- van den Bergh KA, Essink-Bot ML, Borsboom GJ et al. Long-term effects of lung cancer computed tomography screening on health-related quality of life: the NELSON study. Eur Respir J 2011; 38(1):154-61.
- American Cancer Society. Lung Cancer (non-small cell). Last revised July, 2011. Available online at www.cancer,org. Last accessed September 2011.
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Policy History:
Date Reason Action
October 2010 Annual review Policy renewed
September 2011 Annual review Policy revised
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*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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